UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025970 |
|---|---|
| Receipt number | R000020592 |
| Scientific Title | The effect of toe grip strenth on the prognosis of patients with total knee arthroplasty |
| Date of disclosure of the study information | 2017/02/02 |
| Last modified on | 2024/01/11 16:38:43 |
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Basic information
Public title
The effect of toe grip strenth on the prognosis of patients with total knee arthroplasty
Acronym
The effect of toe grip strenth on TKA
Scientific Title
The effect of toe grip strenth on the prognosis of patients with total knee arthroplasty
Scientific Title:Acronym
The effect of toe grip strenth on TKA
Region
| Japan |
Condition
Condition
osteoarthritis of the knee
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the relationship between toe grip strength and the prognosis of patients with total knee arthroplasty and the effect of strengthening of toe grip strength on tne prognosis of them.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
toe grip strength and physical function in one and three month
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
a regular physical therpy and strength exercise of toe grip for a month
Interventions/Control_2
a regular physical therapy for a month
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patitents with no past history of severe disease or injury in lower extremity
Key exclusion criteria
patient with cognitive function decline
patient with any impairment of lower extremity or gait impairment for a reason other than osteoarthritis of the knee
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Uritani |
Organization
Kio University
Division name
Faculty of Health Science
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
d.uritani@kio.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Uritani |
Organization
Kio University
Division name
Faculty of Health Science
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
Homepage URL
d.uritani@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Japanese society of promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
Tel
0745541601
soumu@kio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
市立伊丹病院（兵庫県）福岡志恩病院（福岡県）、香芝旭ヶ丘病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 02 | Day |
Related information
URL releasing protocol
http://www.jaompt.com/journal/pdf/vol1-1.pdf
Publication of results
Published
Result
URL related to results and publications
http://www.jaompt.com/journal/pdf/vol1-1.pdf
Number of participants that the trial has enrolled
67
Results
Preoperative TUG (12.5(4.9) sec) was
significantly delayed at the postoperative period (vs 14.5(5.1) sec preoperatively). In
multivariate linear regression analyses, TUG had a significant association with age
(standardised partial regression coefficient =0.30) and TGSpre/wt (-0.31).
Results date posted
| 2022 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were sixty-seven patients who underwent TKA.
Participant flow
Participants were recruited at three hospitals.
Adverse events
None
Outcome measures
Toe Grip Strength(TGS)
Preoperative TGS/weight
Isometric knee extension strength (IKES)
Timed Up and Go
Pain during walking
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 02 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020592
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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